The Food and Drug Administration (FDA) Philippines on Thursday warned the public against the use of powdered gloves.
In an advisory, the FDA cited the Medical Device Bans which the US Food and Drug Administration has recently issued regarding the risks posed by powdered gloves.
“The Food and Drug Administration (FDA or Agency) has determined that Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling,” according to the US FDA advisory.
“In order to ensure safety, FDA Philippines shall adopt the use of powder-free medical gloves,” Nela Charade Puno, FDA Philippines’ director general said in an advisory.
She added that the health agency shall implement the gradual switching to powder-free gloves and eventually phase out powdered gloves, and shall be completed by the end of 2018.
“All healthcare professionals and the general public are hereby informed of the gradual phasing out of powdered gloves and it’s eventually phase out by end of 2018 in Philippine market,” Puno said.
The advisory shall cover the importation, distribution, manufacture, storage, distribution, and use of (1) powdered surgeon’s gloves; (2) powdered patient examination gloves; and (3) absorbable powder for lubricating a surgeon’s glove.
“However, this ban does not apply to (1) powdered radiographic protection gloves; (2) powder used in the manufacturing process of non-powdered gloves; and (3) powder intended for use in or on other medical devices, such as condoms,” the FDA clarified.
It added that the advisory shall take effect on 01 January 2019, therefore, all applications for product certification and/or other authorization for powdered gloves shall not be allowed.
“All valid Certificate of Product Registrations issued prior to December 31, 2018 shall be revoked/terminated/cancelled as this pose potential danger to clinician and patient and/or consuming public,” the FDA said.
The FDA hereby warns the public that any importation/selling/manufacturing/distribution or offering for sale of the abovementioned medical devices after 31 December 2018 shall be considered as a direct violation of Republic Act No. 9711 or the Food and Drug Administration Act of 2009.
For more information and inquiries or to report continuous sale or distributions of banned medical device, e-mail cdrrhr_prsdd@fda.gov.ph or call (02) 857-1900 local 8301. JPV